510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 1015 of 3531

510(k) clearances, page 1015 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101557	Gamma-Bsm, Beta-Bsm, Equivabone, Carigen	Etex Corp.	MQV	Class II	2010-07-01
K101512	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watchbp Office Target (Bp3md1-4).	Microlife Intellectual Property GmbH	DXN	Class II	2010-07-01
K101457	Easyplus Mini R9n Self Monitoring Blood Glucose System Model Eps10031	Eps Bio Technology Corp.	NBW	Class II	2010-07-01
K101293	Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)	Pt. Smartglove Indonesia	LZA	Class I	2010-07-01
K101190	Lightstim Anti-Wrinkle OTC Model Aal OTC	LED Intellectual Properties LLC	OHS	Class II	2010-07-01
K101135	Powder Free Vinyl Patient Examination Gloves (Yellow, White,blue, Pink)	Hongze Plastic Technology Co., Ltd.	LYZ	Class I	2010-07-01
K101132	Powder Free Vinyl Patient Examination Gloves, (Blue, White, Pink)	Hong di Plastic Products Co., Ltd.	LYZ	Class I	2010-07-01
K101085	Spinesmith Cynch Spinal System	Spine Smith Partners L.P.	MAX	Class II	2010-07-01
K100936	Gynecare Tvt Abbrevo Continence System	Ethicon, Inc	OTN	Class II	2010-07-01
K100817	Biosign Ifobtest, Biosign Fecal Occult Blood Test	Princeton BioMeditech Corp.	KHE	Class II	2010-07-01
K100816	Pk Superpulse Sysem Generator Model 744000	Gyrus ACMI, Inc.	GEI	Class II	2010-07-01
K100757	Tilock Pedicle Screw System	Genesys Spine	NKB	Class II	2010-07-01
K100661	Earprobe	Path Medical GmbH	GWJ	Class II	2010-07-01
K100634	Synthes Matrix System	Synthes (USA) Products LLC	NKB	Class II	2010-07-01
K100275	Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection Electrode Loops and Bands	Olympus Winter & Ibe GmbH	FAS	Class II	2010-07-01
K100059	Powder Free Vinyl Patient Examination Gloves, Colored (White)	Tangshan Zhongpu Plastic Products Co., Ltd.	LYZ	Class I	2010-07-01
K093877	Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26	Edwards Lifesciences LLC	DYB	Class II	2010-07-01
K092399	Anti-Mutated Citrullinated Vimentin Eia	Orgentec Diagnostika GmbH	OQZ	Class II	2010-07-01
K101612	Zen Cordless Prophy System	Discus Dental LLC	EKX	Class I	2010-06-30
K101575	Apex Modular Head, Size 28 ,32, 26 and 40 Mm+10.5 Offset, Models 302810, 303210,303610,304010	Omnlife Science	LPH	Class II	2010-06-30
K101491	Uroskop Omnia	Siemens Medical Solutions USA, Inc.	JAA	Class II	2010-06-30
K100373	Tyche Pedicle Screw System	Kyung Won Medical Co., Ltd.	MNH	Class II	2010-06-30
K094042	Peek Prevail Cervical Interbody Device	Medtronic Sofamor Danek	OVE	Class II	2010-06-30
K093993	Lipiscan Ivus Imaging System Model Nirs-Mc7-70	Nipro Vascular Innovations Americas, Inc.	OGZ	Class II	2010-06-30
K092815	S-Lif Intervertebral Body Fusion Device	SPINEFRONTIER, Inc. dba LESspine Innovations	MAX	Class II	2010-06-30
K090803	Hanson Medical Facial Implants	Hanson Medical, Inc.	FZE	Class II	2010-06-30
K101713	Lipcollector II	Human Med AG	MUU	Class II	2010-06-29
K101502	Bd Vacutainer Rapid Serum Tube Blood Collection Tube, Model 368774	Becton Dickinson & Co	JKA	Class II	2010-06-29
K101378	Frankenman Surgical Staplers	Suzhou Frankenman Medical Equipment Co., Ltd.	GDW	Class II	2010-06-29
K101253	Rii Infrared Ear Thermometer, Model: Th60n	Radiant Innovation Inc.	FLL	Class II	2010-06-29
K101178	Modification to Intel Health Guide Phs6000	Intel Corp.	DRG	Class II	2010-06-29
K100940	Fully Automatic Electronic Blood Pressure Monitor, Model Kd-5965	Andon Health Co., Ltd	DXN	Class II	2010-06-29
K100562	Latitude Elbow Prosthesis	TORNIER Inc.	JDB	Class II	2010-06-29
K100285	Litetouch Mask	Respironics New Jersey, Inc.	CAF	Class II	2010-06-29
K093517	Nitritech or Multiple Private Label Non-Sterile Powder Free Nitrile Patient Examination Glove	Summit Glove, Inc.	LZA	Class I	2010-06-29
K093516	Nitritech or Multiple Private Label Non Sterile Powdered Nitrile Examination Gloves	Summit Glove, Inc.	LZA	Class I	2010-06-29
K092992	A4-Xlr8 Foam Dressing	Genadyne Biotechnologies, Inc.	OMP	Class II	2010-06-29
K092720	Wrist Arthrodesis Nail System	Skeletal Dynamics, Inc	HSB	Class II	2010-06-29
K092625	Wavestate Neuromonitor	Wavestate, Inc.	ORT	Class II	2010-06-29
K101344	G+ System	Glytec, LLC (Formally Known AS Glucotec, Inc.)	NDC	Class II	2010-06-28
K100947	Finesse Personal Insulin Delivery Patch, Model Fg 2000	Calibra Medical, Inc.	OPP	Class II	2010-06-28
K100322	Td-4277 Blood Glucose Monitoring System, Model 4277	Taidoc Technology Corporation	NBW	Class II	2010-06-28
K092985	Bellecup	Librette, Inc.	HHE	Class II	2010-06-28
K091807	Medpor Fixation System	Porex Surgical, Inc.	JEY	Class II	2010-06-28
K101671	Single Site Flexible Bladeless Obturator	Teleflexmedical, Inc.	GCJ	Class II	2010-06-25
K101639	Cg-6108 Act-Il Continuous ECG Monitor and Arrythmia Detector	Card Guard Scientific Survival, Ltd.	DSI	Class II	2010-06-25
K101431	Eclipse Filter System-Femoral and Jugular/subclavian Delivery Kits	C.R. Bard Inc	DTK	Class II	2010-06-25
K101091	Z.one Ultra Ultrasound System	Zonare Medical Systems, Inc.	IYN	Class II	2010-06-25
K101018	Cardica C-Port Xa Plus Distal Anastomosis System, Model Fg-000100	Cardica, Inc.	FZP	Class II	2010-06-25
K100995	Shikani Speaking Valve	Shikani Medical LLC	JOH	Class II	2010-06-25